Risk Of Severe Hepatic Injury In Patients With Invasive Candidiasis Treated With Echinocandins

NCT01213823 | Terminated Results

• 1 other identifier: A8851024
• Study Type: observational
• Target: 536
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to estimate the relative risk of severe hepatic injury in hospitalized patients with invasive candidiasis and candidemia who received anidulafungin, compared to patients who received caspofungin and/or micafungin.

Conditions

Invasive Candidiasis; Candidemia

Keywords

invasive candidiasis; candidemia; severe hepatic injury; echinocandins; anidulafungin; caspofungin; micafungin

Outcome Measures

Primary Outcomes (1)

• Number of Any Severe Hepatic Injury Cases and Matched Controls

  Severe hepatic injury (acute/subacute necrosis of liver, hepatic coma, hepatorenal syndrome, or hepatitis unspecified) classified as: 1) acute liver failure (associated with encephalopathy and/or coagulopathy in absence of underlying liver disease); 2) Hy's Law Criteria (serum alanine transaminase \[ALT\] levels greater than \[\>\]3 times the upper limit of normal \[ULN\] and direct bilirubin \>2 times ULN and absence of alkaline phosphatase elevation); 3) ALT levels greater than or equal to (≥) 10 times ULN; 4) ALT levels \>3 times ULN and less than (\<) 10 times ULN; or 5) classified by clinician. Disease Related Group (DRG) severity of illness coding was reported for severe hepatic injury cases and matched controls.

  01 June 2006 to 30 June 2008 (up to 25 Months)

Study Arms (2)

Cases

Potential cases were defined as patients with a diagnosis of severe hepatic injury identified in the acute-care inpatient cohort using ICD-9 codes associated with the case definition of severe liver injury. Case status was validated by a Consultant Gastroenterologist blinded to study drug exposure via medical record review using an apriori algorithm. Only validated cases were included in the analysis (N=69)

Other: Does not apply

Controls

Controls were defined as patients without a diagnosis of severe hepatic injury (i.e. with no ICD-9 codes associated with the case definition of severe liver injury) selected at random from the same acute-care inpatient cohort as cases (N=467)

Other: Does not apply

Interventions

Does not apply OTHER

This is a non-interventional study, therefore the intervention type / name do not apply

Cases

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acute-care inpatients aged 18 years or older, with at least one dose of echinocandin antifungal therapy during the hospitalization and a primary or secondary ICD-9 discharge diagnosis of invasive candidiasis / candidemia identified in the Premier's PerspectiveTM Comparative Database (PCD) from 01 June 2006 to 30 June 2008.

You may qualify if:

• Acute-care inpatients;
• Aged 18 years or older;
• At least one dose of echinocandin therapy during the hospitalization;
• Primary or secondary ICD-9 discharge diagnosis of invasive candidiasis / candidemia.

You may not qualify if:

• \< 18 years of age;
• No recorded echinocandin therapy during hospitalization;
• Acetaminophen hepatotoxicity;
• Pre-existing autoimmune hepatitis;
• Autoimmune/metabolic liver disease;
• Primary biliary cirrhosis;
• Primary sclerosing cholangitis and orthotopic liver transplantation.

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Candidiasis, Invasive; Candidemia

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Fungemia; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Study results were invalidated due to lack of temporality, a critical methodological element of the study that was never established for the majority of the cases of severe hepatic injury.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 4, 2010
• Study Start: September 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: March 30, 2016
• Results First Posted: February 4, 2016

Record last verified: 2016-03